Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

Karilyn Gower, Press Officer
w. (202) 588-7779

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter


Jan. 23, 2012 

FDA Should Not Approve Drug That Is Likely to Cause Life-Threatening Lung Toxicity

In Drug to Treat Schizophrenic and Bipolar Patients, Benefits Do Not Outweigh Risks

WASHINGTON, D.C. – A proposed new drug to treat acute agitation in patients with schizophrenia and bipolar disease should not be approved by the Food and Drug Administration (FDA) because the drug has been shown to cause significant, life-threatening lung toxicity and fails to provide any significant benefits in comparison to currently available, FDA-approved alternative drugs, Public Citizen said in a letter sent today to the agency.

The drug, loxapine inhalation powder (also known as Adasuve), manufactured by Alexza Pharmaceuticals, is the first inhaled form of an antipsychotic for use in schizophrenic or bipolar patients. Loxapine already is approved in a capsule form for long-term treatment of schizophrenia, but Alexza is seeking approval for an inhaled form that would be administered for acute agitation as frequently as every two hours as needed, up to a maximum of three doses per day. Action by the FDA on the drug is expected to occur by May 4.

But the drug can cause significant abnormalities in lung function and high rates of pulmonary adverse events – such as bronchospasm, chest discomfort, wheezing and shortness of breath – particularly in patients with asthma and chronic obstructive pulmonary disease COPD (also known as chronic bronchitis and emphysema). Because there is a high rate of smoking in patients with schizophrenia and bipolar disorder, which leads to the development of asthma and COPD, such patients would be particularly prone to developing serious lung toxicity from inhaled loxapine.

In fact, in one safety study testing inhaled loxapine in patients with asthma, approximately 60 percent of the patients had clinically significant abnormalities developed immediately after a single dose of the drug, and approximately 20 percent could not receive a planned second dose because of adverse respiratory events. In a different safety study, which examined the drug in patients with COPD, results were similar.

“Even a single dose of inhaled loxapine resulted in significant pulmonary toxicity in safety trials designed to evaluate inhaled loxapine,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The risks of this drug greatly outweigh its limited benefits. Allowing it to be marketed, even at a single dose, would result in many preventable injuries and deaths.”

FDA reviewers expressed serious concerns about the potential for life-threatening pulmonary toxicity with inhaled loxapine and even questioned the benefits offered by the drug. One FDA reviewer was skeptical whether conclusions from the clinical trials could be extrapolated to the real-word setting – particularly in psychiatric emergency room settings, which likely would be a common setting for use, the letter said. Another reviewer doubted whether inhaled loxapine offered any advantages over current FDA-approved treatments for these patients.

Indeed, one FDA official stated that, in order for the drug to be approved, the company should “be required to submit adequate data on a formulation of the Staccato Loxapine product that demonstrates a lack of pulmonary toxicity.” Such data do not exist.

“As the FDA’s own analysis demonstrated, there is no reasonable justification for approving this drug, and doing so would recklessly endanger patients’ lives,” Carome said.


Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.